BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCLOSE¿ PROSTYLE¿

    MDR report key: 20738744 · Received November 20, 2024

    Report

    Report Number
    2024168-2024-13781
    Event Type
    Injury
    Date Received
    November 20, 2024
    Date of Event
    October 31, 2024
    Report Date
    January 7, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    MGB
    UDI-DI
    08717648344039
    PMA / PMN Number
    P960043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. ANALYSIS OF THE RETURNED DEVICE FOUND A NEEDLE TIP SEPARATION. THE DETACHED NEEDLE TIP WAS NOT RETURNED WITH THE PROGLIDE DEVICE. THE REPORTED NEEDLE TO CUFF MISS WAS CONFIRMED. THE REPORTED MECHANICAL JAM WITH THE PLUNGER ¿PRESSING THE PLUNGER WAS NOT POSSIBLE¿ COULD NOT BE CONFIRMED AS THE EXACT CONDITIONS ENCOUNTERED BY THE DEVICE DURING THE PROCEDURE COULD NOT BE REPLICATED IN THE TEST ENVIRONMENT. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED THERE IS NO INDICATION OF A LOT SPECIFIC ISSUE. BASED ON THE REPORTED INFORMATION AND THE OBSERVATIONS FROM THE RETURNED ANALYSIS, THE INVESTIGATION DETERMINED THAT THE REPORTED ISSUE APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. IT IS LIKELY THAT INTERACTION WITH THE PATIENT CALCIFICATION CONTRIBUTED TO THE REPORTED DIFFICULTY DEPLOYING THE PLUNGER. THIS INTERACTION SUBSEQUENTLY CONTRIBUTED TO THE POSTERIOR NEEDLE TO CUFF MISS. THE REPORTED SUBSEQUENT TREATMENT APPEARS TO BE RELATED TO PROCEDURE CIRCUMSTANCE. BASED ON THE RESULTS OF THE COMPLAINT INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. CORRECTIONS: D4 ¿ MODEL #, D4 - CATALOG #: UPDATED FROM UNK PROSTYLE TO 12773-02. D4 ¿ LOT #: UPDATED FROM UNKNOWN TO 4092341. D4 - PRIMARY UDI NUMBER: UPDATED FROM UNKNOWN TO (B)(4).

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. THE ADDITIONAL DEVICE REFERENCED IN B5 IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER. D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED. REPORTEDLY, WHEN USING THE SECOND PROSTYLE DEVICE, THERE WAS RESISTANCE IN THE TISSUE AND THE PLUNGER COULD NOT BE PUSHED THROUGH, RESULTING IN A CUFF MISS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS AN ARTERIOTOMY CLOSURE OF THE CALCIFIED RIGHT COMMON FEMORAL ARTERY USING THE PRE-CLOSE TECHNIQUE PRIOR TO A TRANSCATHETER AORTIC VALVE IMPLANTATION PROCEDURE. REPORTEDLY, THE FIRST PROSTYLE DEVICE WAS PLACED WITHOUT ISSUE. HOWEVER, WHEN USING THE SECOND PROSTYLE DEVICE, PRESSING THE PLUNGER WAS NOT POSSIBLE. THE SUTURE OF A THIRD PROSTYLE DEVICE WAS PRE-PLACED. THE SHEATH WAS UPSIZED TO A LARGE-BORE SHEATH, AND THE INTERVENTIONAL PROCEDURE WAS COMPLETED. THE KNOT OF THE FIRST AND THIRD PRE-PLACED SUTURE WAS ADVANCED TO THE VESSEL WALL HOWEVER HEMOSTASIS WAS NOT ACHIEVED. A NON-ABBOTT DEVICE WAS ADDED. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2426809 PERCLOSE¿ PROSTYLE¿ DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR INC. 12773-02 4092341 08717648344039

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention PROSTYLE SUTURE